Home Health US, Incorporated: Device Recall
Recall #Z-0226-2026 · 07/25/2025
Class III: Low Risk
Recall Details
- Recall Number
- Z-0226-2026
- Classification
- Class III
- Product Type
- Device
- Recalling Firm
- Home Health US, Incorporated
- Status
- Ongoing
- Date Initiated
- 07/25/2025
- Location
- Sarasota, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,661 lancets
Reason for Recall
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Product Description
One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.
Distribution Pattern
U.S.: Nation-wide distributed thru Amazon U.S. States include: AZ, CA, FL, IL, NC, NM, NY, TN, TX, and VA. O.U.S.: N/A
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.